The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of \[14C\]TD-9855
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
radiolabeled (100 µCi \[14C\]-Labeled) TD-9855 (20 mg)
Unnamed facility
Lincoln, Nebraska, United States
To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855
Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.
Time frame: 1-21 Days
Pharmacokinetics of total drug-related material and TD-9855: Cmax
Whole blood and plasma concentrations
Time frame: 1-21 Days
PK: Tmax
Whole blood and plasma concentrations
Time frame: 1-21 Days
PK: AUCt
Whole blood and plasma concentrations
Time frame: 1-21 Days
PK: AUCinf
Time frame: 1-21 Days
PK: CL/F (Renal clearance)
Urine
Time frame: 1-21 Days
PK: Vz/F (oral volume of distribution during the terminal phase)
Time frame: 1-21 Days
PK: amount excreted in urine (Ae)
Urine
Time frame: 1-21 Days
PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)
Urine
Time frame: 8-21 Days
Metabolic profiles in plasma and excreta
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Time frame: 1-21 days